Senior Scientist - Quality Control (Analytical)

Proclinical, in support of their client, are seeking a talented individual to fill the role of Senior Scientist, Quality Control (Analytical) based in Gaithersburg, MD. The successful candidate will have a strong analytical and compliance background, and will possess proven leadership skills to establish the Analytical Technical Support team as scientific experts within the Quality Control department.

Responsibilities

• Responsible for the QC analytical lifecycle management program post method qualification.
• Author transfer/validation protocols and reports.
• Collaborate with Analytical Development regarding the introduction of new analytical technologies and instrumentation.
• Troubleshoot and investigate trends in performance of analytical methods used for release/stability and in-process assays.
• Provide analytical technical expertise for manufacturing deviations and OOS/OOT investigations by working in concert with Manufacturing and QA.
• Serves as the technical liaison between Quality Control and Analytical Development
• Represent QC on cross-functional teams focused on solving relevant issues.
• Oversee and manage method transfer and assay validation programs.
• Authors transfer/validation protocols and reports, as well as deviations and investigations.
• Collaborate with Analytical Development in the execution of method transfers and validations.
• Deliver analytical source documentation for CMC sections of IND/BLA filings.
• Address technical inquiries from regulatory agencies to support clinical trial and commercial marketing applications.

Skills And Qualifications

• MA in Biochemistry, Chemistry, or related scientific discipline 10+ years of relevant industry experience.
• Demonstrated scientific knowledge and experience in analytical methodologies used for Large Molecules.
• Broad knowledge and experience in method transfers and validations.
• Knowledge of applicable global drug development and regulatory standards and current expectations.
• Knowledge and application of cGMPs/GLPs, ICH, FDA CMC Guidance Documents.
• Experience with CMC technical sections of regulatory submissions and addressing regulatory authorities on technical matters.
• Strong written, verbal, and interpersonal communication skills.
• Successful application of OE tools/methodologies with demonstrated business results.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Jason Thiagaram at (+1) 646-367-2910 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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